Ultrasound Barrier Devices and Methods Related Thereto

ABSTRACT

In one aspect, the present subject matter is directed to a barrier device. The barrier device has a generally flat base with a width and a length. The base has a top portion and an opposite bottom portion. A surface of the bottom portion includes adhesive. A barrier extends upwardly from the base, the barrier having a generally flat first side and an opposite generally flat second side. A width between the first side of the barrier and the second side of the barrier is less than the width of the base.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is based on and claims priority to U.S.Provisional Application 61/726,929 having a filing date of Nov. 15,2012, which is incorporated by reference herein.

BACKGROUND

In medicine, ultrasound has become one of the most utilized imagingmethods. Ultrasound applications employ a transducer that generates andsends ultrasound waves into a patient. Ultrasound can be used to guideneedles and catheters to a site under the skin for biopsies andinsertion into blood vessels. These ultrasound guided techniques havedramatically increased the accuracy of hitting the target blood vesselor tissue while decreasing the number of complications of suchprocedures performed without ultrasound. However, since an ultrasoundprobe is not sterile, there exists a risk of introducing infection ifthe probe crosses into the area where the needle or catheter puncturesthe skin.

To decrease the likelihood of infection from the probe, sterileultrasound kits are typically used that include a sterile cover for theprobe, sterile ultrasound gel that is needed as a contact with the skinsurface to use the probe, and/or sterile drapes. These kits addsignificant cost to the procedure, take time to prepare and use, andgenerally require two individuals to use—the person performing theprocedure and an assistant.

As such, it would be desirable to provide a device that provides asterile barrier between a puncture site and an ultrasound probe sitewithout the aforementioned limitations. Methods relating to such adevice would also be desirable.

SUMMARY

Aspects and advantages of the invention will be set forth in part in thefollowing description, or may be obvious from the description, or may belearned through practice of the invention.

In one aspect, the present subject matter is directed to a barrierdevice. The barrier device has a generally flat base with a width and alength. The base has a top portion and an opposite bottom portion. Asurface of the bottom portion includes adhesive. A barrier extendsupwardly from the base, the barrier having a generally flat first sideand an opposite generally flat second side. A width between the firstside of the barrier and the second side of the barrier is less than thewidth of the base.

In yet another aspect of the present disclosure, a method for utilizinga barrier device with an ultrasound guided procedure is described. Themethod includes positioning a barrier device on a patient. The methodfurther includes positioning an ultrasound probe adjacent to the secondside of the barrier and positioning a needle adjacent to the first sideof the barrier, wherein the barrier separates the ultrasound probe andthe needle.

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the invention and, together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof, directed to one of ordinary skill in the art, is setforth in the specification, which makes reference to the appendedfigures, in which:

FIG. 1 depicts a perspective view of a device in accordance with certainexemplary embodiments of the present disclosure; and

FIG. 2 depicts and expanded view of a device in accordance with certainexemplary embodiments of the present disclosure.

DETAILED DESCRIPTION

Reference now will be made in detail to embodiments of the invention,one or more examples of which are illustrated in the drawings. Eachexample is provided by way of explanation of the invention, notlimitation of the invention. In fact, it will be apparent to thoseskilled in the art that various modifications and variations can be madein the present invention without departing from the scope or spirit ofthe invention. For instance, features illustrated or described as partof one embodiment can be used with another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncovers such modifications and variations as come within the scope of theappended claims and their equivalents.

The present disclosure is generally directed to a barrier device for usewith ultrasound guided procedures. The barrier device of the presentdisclosure can be adhered to a patient so that an ultrasound probe isutilized on one side of the barrier device and a needle or otherinstrument is positioned on the other side of the ultrasound device. Inparticular, the devices described herein prevent a non-sterileultrasound probe and/or ultrasound gel from moving to a sterile surfacenear an injection site. The devices of the present disclosure can beutilized to create a wall to prevent contamination of a puncture site toreduce infection risk.

Advantageously, the present disclosure allows for ultrasound guidedprocedures to be completed more quickly and without requiring anassistant as is typically needed. The barrier devices described hereinare also more cost effective than pre-packaged ultrasound sterilitykits.

Referring to FIG. 1, a barrier device 10 in accordance with the presentdisclosure is illustrated. The device 10 is positioned on a patient'sknee 50. However, the device 10 of the present disclosure can bepositioned at any suitable location to provide a barrier between anultrasound probe and an instrument, such as a needle.

The device 10 includes a base 12 having a width 14 and length 16.Measurements for length and width can vary depending on the locationthat device 10 is to be positioned but length can generally be fromabout 10 mm to about 100 mm and a width can generally be from about 1 mmto about 50 mm. In certain aspects of the present disclosure, the widthof the base can narrow (as is illustrated) to a second width such thatthe width is similar to that of barrier 30 (as will be described ingreater detail herein). Base 12 also includes a top portion 18 andbottom portion 20 (shown in FIG. 2).

FIG. 2 illustrates an expanded view of device 10 in accordance withcertain aspects of the present disclosure. Device 10 can be formed byfolding a generally rectangular shaped material 40 along fold 60 so asto create base 12 and barrier 30. Bottom portion 20 of base 12 includesadhesive 22 to adhere device 10 to patient. Any suitable adhesive can beutilized. For example, a silk tape, such as Durapore® Tape availablefrom 3M Company, or any type of similar adhesive tape suitable formedical use can be utilized that does or does not include a protectivestrip covering the adhesive. Adhesive 22 can be located around one ormore of top, bottom, and/or sides of the perimeter 24 of base 12.

Turning back to FIG. 1, barrier 30 extends upwardly from base 12.Barrier 30 is designed to separate ultrasound probe 70 from instrumentinsertion site 80. In this regard, barrier can be formed of asubstantially rigid material so that barrier remains upright when deviceis placed on patient. Referring to FIG. 2, in certain aspects of thepresent disclosure, one or more additional elements, such as insert 42can be utilized to provide sufficient rigidity to barrier 30. Forinstance, as shown, when generally rectangular shaped material 40 isfolder over itself, insert 42 can be placed on one side of fold line 60and sandwiched by material 40 so as to reinforce the portion of material40 that becomes barrier 30. Insert can be any suitable material, such asplastic or the like. Insert can be of any suitable length, width, andthickness. For example, in certain aspects of the present disclosure,insert can have a length of from about 10 mm to about 95 mm, a width offrom about 1 mm to about 5 mm, and a thickness of from about 0.5 mm toabout 2 mm. In addition, any other suitable rigidity enhancing elementas would be understood by one of ordinary skill in the art can beutilized as well.

With reference again to FIG. 1, barrier 30 can include a first side 32and an opposite second side 34. The barrier has a width 36 and length38. For instance, in certain aspects of the present disclosure, thewidth 36 can be measured between first side 32 and second side 34. Suchwidth can be less than width 14 of base 12. Measurements for length andwidth can vary depending on the location that device is to be positionedbut length can generally be from about 10 mm to about 100 mm and widthcan be from about 1 mm to about 10 mm. Barrier 30 can be generallyperpendicular to base 12.

While illustrated as being generally flat, barrier can have a curvedshape or any other suitable to accommodate a curved portion of the body.Similarly, depending on the application, base can be curved or have anyother suitable shape to allow base to adhere flush to patient. Forinstance, in certain aspects of the present disclosure, both base andbarrier can be rounded to accommodate positioning on a joint of apatient.

The device 10 can be constructed of one or more materials of suitablestrength that are acceptable for medical applications. Base 12 andbarrier 30 can be formed from the same material or from differentmaterials. In certain aspects, as described above, base 12 and barrier30 are formed from folding a single piece of material. The material canbe flexible, latex-free, and antimicrobial. The material should besufficient to be impervious to blood or other body fluids. Suitablematerials can include woven fabrics, polymers, or the like, namelypolyolefin film, polyurethane polymer, polyethylene, polyethylene vinylacetate, polyurethane foam, and can also be made from a textile,non-woven material, rubber, and the like. As described previously,adhesive can be affixed to one portion of the device or material cansimply include adhesive attributes, such adhesive being similarlysuitable for medical applications.

Device can be configured to be folded and packaged so as to be easilyshipped and sold. For instance, similar to a conventional bandage,barrier device can include a disposable package and that incorporatesone or more protective strips as a part thereof over adhesive portions.For instance, in certain aspects of the present disclosure, bottomportion of base can include a protective strip while barrier can befolded over bottom portion so that the entire device can be packaged asa generally flat device. Upon unwrapping device from packaging, barriercan be folded upright and device can be placed on patient. In thismanner, device can be remain sterile and easy to package prior to use.

In use, a health care worker can clean the area on patient at which anultrasound guided procedure is to take place using conventionalsterilizing methods. The worker can then remove a protective strip (notshown) covering the adhesive layer and place the device 10 on patient,such as illustrated patient knee 50. Ultrasound gel (not shown) can beapplied on and around the location of intended ultrasound on one side ofdevice 10. Ultrasound probe 70 can be positioned adjacent to one side ofdevice 10 and instrument 80, such as the illustrated needle, can beinserted into patient with guidance from ultrasound probe 70 on otherside of device 10. In this manner, the disclosed barrier device of thepresent disclosure can create a wall of protection from contamination ofthe area on the skin to be punctured by a needle or catheter inultrasound guided procedures. The barrier device separates the areawhere the non-sterile ultrasound probe is used in identifying the targetsite below the skin and the area that is sterilized before puncture,decreasing the risk of infection to the patient. Using the barrierdevice reduces the time, cost, and additional personnel presentlynecessary to perform ultrasound guided procedures using a standardultrasound kit. The barrier device of the present disclosure can be aneffective, efficient, and cost effective alternative to the presentmethods of performing ultrasound guided procedures since ultrasoundguided procedures are rapidly increasing in numbers across many areas ofmedicine.

While the present subject matter has been described in detail withrespect to specific exemplary embodiments and methods thereof, it willbe appreciated that those skilled in the art, upon attaining anunderstanding of the foregoing may readily produce alterations to,variations of, and equivalents to such embodiments. Accordingly, thescope of the present disclosure is by way of example rather than by wayof limitation, and the subject disclosure does not preclude inclusion ofsuch modifications, variations and/or additions to the present subjectmatter as would be readily apparent to one of ordinary skill in the art.

What is claimed is:
 1. A barrier device comprising: a generally flatbase with a width and a length, the base comprising a top portion and anopposite bottom portion, a surface of the bottom portion comprisingadhesive; and a barrier extending upwardly from the base, the barrierhaving a generally flat first side and an opposite generally flat secondside, a width between the first side of the barrier and the second sideof the barrier being less than the width of the base.
 2. The device ofclaim 1, wherein the barrier is substantially rigid.
 3. The device ofclaim 1, wherein the base and the barrier comprise the same material. 4.The device of claim 3, wherein the material is a latex-free polymer. 5.The device of claim 3, wherein the material is non-permeable.
 6. Thedevice of claim 3, wherein the material is antimicrobial.
 7. The deviceof claim 1, wherein the barrier is generally perpendicular to the base.8. The device of claim 1, wherein the base has a second width, thesecond width being generally equal to the width between the first sideof the barrier and the second side of the barrier.
 9. The device ofclaim 1, further comprising a rigid element sandwiched between the firstside of the barrier and the second side of the barrier.
 10. The deviceof claim 9, wherein the rigid element comprises plastic.
 11. The deviceof claim 1, wherein the adhesive is located on a perimeter of the base.12. A method for utilizing a barrier device with an ultrasound guidedprocedure, the method comprising: positioning a barrier device on apatient, the barrier device comprising a generally flat base with awidth and a length, the base comprising a top portion and an oppositebottom portion, a surface of the bottom portion comprising adhesive thatadheres the base to the patient, the barrier device further comprising abarrier extending upwardly from the base, the barrier having a generallyflat first side and an opposite generally flat second side, a widthbetween the first side of the barrier and the second side of the barrierbeing less than the width of the base; positioning an ultrasound probeadjacent to the second side of the barrier; and positioning aninstrument adjacent to the first side of the barrier, wherein thebarrier separates the ultrasound probe and the needle.
 13. The method ofclaim 12, wherein the barrier is substantially rigid.
 14. The method ofclaim 12, wherein the base and the barrier comprise the same material.15. The method of claim 14, wherein the instrument is a needle.
 16. Themethod of claim 14, wherein the material is antimicrobial.
 17. Themethod of claim 12, wherein the barrier is generally perpendicular tothe base.
 18. The method of claim 12, wherein the base has a secondwidth, the second width being generally equal to the width between thefirst side of the barrier and the second side of the barrier.
 19. Themethod of claim 12, further comprising a rigid element sandwichedbetween the first side of the barrier and the second side of thebarrier.
 20. The method of claim 19, wherein the rigid element comprisesplastic.